Clinical Trials Logo

Clinical Trial Summary

In this prospective, randomized controlled study, n=140 female students with functional constipation studying at two universities Faculty of Health Sciences and meeting the Rome-IV Diagnostic Criteria for Constipation will be included in the study. Between 15.03.2024 and 31.05.2024, n=140 (35=control group, 35=kegel exercise group, 35=abdominal exercise group, 35=abdominal and kegel exercise group) volunteered to participate in the study. Female students with functional constipation will be randomly divided into four groups as intervention and control groups. Personal Information Form", "Bristol Stool Scale", "Constipation Severity Scale", and "Patient Assessment of Constipation Quality of Life Questionnaire" will be used in this study. The scales will be used in the research two times: pre and post-test (scales were reassessed at the end of the study after the exercise intervention). Descriptive statistics, Pearson, and Spearman's correlation analyses will be used in the analysis of research data.


Clinical Trial Description

This study aimed to investigate the effect of abdominal massage and kegel exercises on constipation and quality of life in female students with functional constipation. Type of Research: This study was conducted in a prospective, four-arm, and randomized controlled manner. Female students with functional constipation studying at two universities Faculty of Health Sciences and meeting the Rome-IV Diagnostic Criteria for Constipation will be included in the study. The power analysis of this study was performed with G*POWER 3.1.9.7 (Power analysis statistical software). The sample size of the study was based on the average score of the Patient Assessment of Constipation Quality of Life Questionnaire (Patient Assessment of Constipation Quality of Life Questionnaire). It was determined that 31 individuals from each group would be sufficient to participate in the study with an effect size of 0.64, α = 0.05 margin of error, and minimum power = 80% (β = 0.2). Considering the possible missing data, it was calculated that each group should consist of 35 female students with functional constipation with a 10% increase. Data Collection Tools-Validity and Reliability Information In the study, the "Personal Information Form", "Bristol Stool Scale", "Constipation Severity Scale", and "Patient Assessment of Constipation Quality of Life Questionnaire" will be used. The scales will be used in the research two times: pre and post-test (scales were reassessed at the end of the study after the exercise intervention). Personal Information Form: The information form developed by the researchers by analyzing the literature consisted of 10 questions about sociodemographic characteristics, health status, and variables affecting constipation. Bristol Stool Scale: The type of stool is classified into 7 different groups. In the Bristol Stool Scale, the transit time of the stool through the intestine is evaluated over seven different stool types. According to Bristol Stool Scale, 1-2 points are shown as "hard stool", 3-4-5 points as "normal stool" and 6-7 points as "soft-watery stool (diarrhea)". Constipation Severity Scale: It is a scale for determining the frequency, intensity, and difficulty/difficulty during defecation. In addition, it was aimed to measure the constipation symptoms of the participants through this scale. There are 16 questions on the scale. The scale has three sub-dimensions: fecal obstruction, large bowel laziness, and pain. The score that can be obtained from the Faecal Obstruction sub-dimension is 0-28, the score that can be obtained from the Large Bowel sub-dimension is 0-29, and the score that can be obtained from the Pain sub-dimension is 0-16. The lowest total score that can be obtained from this scale is 0 and the highest score is 73. A high score on the scale indicates that the symptoms are serious. Internal consistency (α = 0.88-0.91) and test-retest reliability (intraclass correlation coefficients = 0.84-0.91) were reported to be high for all subscales. Patient Assessment of Constipation Quality of Life Questionnaire: This scale measures the quality of life in constipation. This is a 28-item self-assessment scale consisting of "Worry/Anxiety" (11 items), "Physical Discomfort" (4 items), "Psychosocial Discomfort" (8 items), and "Satisfaction" (5 items) subscales. The item scores of the five-point Likert-type scale vary between 1-5. The highest score obtained from the scale is 140 and the lowest score is 28. It is thought that quality of life is negatively affected as the scores obtained from the scale increase. The Cronbach alpha reliability coefficient of the scale is 0.91. The Cronbach alpha reliability coefficient of the "Physical Discomfort" subscale is 0.88, the total item correlation coefficient is 0.91, the Cronbach alpha reliability coefficient of the "Psychosocial Discomfort" subscale is 0.87, the total item correlation coefficient is 0. 82, Cronbach alpha reliability coefficient of "Worry and Anxiety" subscale was 0.85, the total item correlation coefficient was 0.84 and Cronbach alpha reliability coefficient of "Satisfaction" subscale was 0.76, total item correlation coefficient was 0.80. The female students included in the study will be taught abdominal massage and kegel exercises by the researcher in an appropriate environment according to the interventional group determined as a result of the randomization assignment. The intervention and control groups will be initially trained on nutrition in constipation. Abdominal massage group (35 students): Abdominal massage is demonstrated by the researchers to a female student with functional constipation. The student will apply exfoliation (superficial and deep), petrissage, and vibration massage movements for about 15 minutes twice a day in the morning and evening hours and at least 30 minutes after the nutritional meal, 5 days a week, for a total of 12 weeks. Kegel exercise group (35 students): 2 times a day in the morning and evening hours, 5 days a week, for a total of 12 weeks. Abdominal massage and kegel exercise group (35 students): students will do both abdominal and kegel exercises for 12 weeks Control group (35 students): No intervention will be made to the control group. Ethical Aspects of the Research For the ethical suitability of the research, The University Rectorate Ethical approval was obtained at the meeting of the Social and Human Sciences Ethics Committee dated 30.01.2024 and numbered "2023-0844" and written permission was obtained from two universities for data collection. Written informed consent is also obtained from the participating students. The research was conducted following the rules of the Declaration of Helsinki. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06290830
Study type Interventional
Source Ondokuz Mayis University
Contact Sükran Basgöl
Phone +903623121919
Email sukran.basgol@omu.edu.tr
Status Not yet recruiting
Phase N/A
Start date March 15, 2024
Completion date June 1, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT06238557 - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04281953 - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting NCT05546931 - Mobile Health Program for Rural Hypertension N/A
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Recruiting NCT04142827 - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) N/A
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT03813420 - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level N/A
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Terminated NCT03304184 - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life Phase 3
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Recruiting NCT05380856 - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction N/A